Systems and methods for interventional procedure planning

ABSTRACT

A method of planning a procedure to deploy an interventional instrument comprises receiving a model of an anatomic structure. The anatomic structure includes a plurality of passageways. The method further includes identifying a target structure in the model and receiving information about an operational capability of the interventional instrument within the plurality of passageways. The method further comprises identifying a planned deployment location for positioning a distal tip of the interventional instrument to perform the procedure on the target structure based upon the operational capability of the interventional instrument.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/144,232 filed Dec. 30, 2013, which claims the benefit of U.S.Provisional Application 61/747,920 filed Dec. 31, 2012, each of which isincorporated by reference herein in its entirety.

FIELD

The present disclosure is directed to systems and methods for navigatinga patient anatomy to conduct a minimally invasive procedure, and moreparticularly to systems and methods for planning a procedure to deployan interventional instrument.

BACKGROUND

Minimally invasive medical techniques are intended to reduce the amountof tissue that is damaged during interventional procedures, therebyreducing patient recovery time, discomfort, and deleterious sideeffects. Such minimally invasive techniques may be performed throughnatural orifices in a patient anatomy or through one or more surgicalincisions. Through these natural orifices or incisions clinicians mayinsert interventional instruments (including surgical, diagnostic,therapeutic, or biopsy instruments) to reach a target tissue location.To reach the target tissue location, a minimally invasive interventionalinstrument may navigate natural or surgically created passageways inanatomical systems such as the lungs, the colon, the intestines, thekidneys, the heart, the circulatory system, or the like. To assist theclinician in navigating the instrument through the passageways, modelsof the passageway are prepared using pre-operative or inter-operativeimaging. Current systems for deploying an interventional instrumentidentify an instrument deployment location as the point within themodeled passageways closest to the target tissue location. Thisclosest-point deployment location may be difficult to access given theconstraints of the interventional instrument or the anatomy. Improvedsystems and methods are needed to determine a planned instrumentdeployment location for conducting a procedure on the target tissuelocation.

SUMMARY

The embodiments of the invention are summarized by the claims thatfollow the description.

In one embodiment, a method of planning a procedure to deploy aninterventional instrument comprises receiving a model of an anatomicstructure. The anatomic structure includes a plurality of passageways.The method further includes identifying a target structure in the modeland receiving information about an operational capability of theinterventional instrument within the plurality of passageways. Themethod further comprises identifying a planned deployment location forpositioning a distal tip of the interventional instrument to perform theprocedure on the target structure based upon the operational capabilityof the interventional instrument.

In another embodiment, a system comprises a non-transitory computerreadable media containing computer executable instructions for planninga procedure to deploy an interventional instrument. The computerexecutable instructions include instructions for receiving a model of ananatomic structure including a plurality of passageways and instructionsfor identifying a target structure in the model. The computer executableinstructions also include instructions for receiving information aboutan operational capability of the interventional instrument within theplurality of passageways and instructions for identifying a planneddeployment location for positioning a distal tip of the interventionalinstrument to perform the procedure on the target structure based uponthe operational capability of the interventional instrument.

BRIEF DESCRIPTIONS OF THE DRAWINGS

Aspects of the present disclosure are best understood from the followingdetailed description when read with the accompanying figures. It isemphasized that, in accordance with the standard practice in theindustry, various features are not drawn to scale. In fact, thedimensions of the various features may be arbitrarily increased orreduced for clarity of discussion. In addition, the present disclosuremay repeat reference numerals and/or letters in the various examples.This repetition is for the purpose of simplicity and clarity and doesnot in itself dictate a relationship between the various embodimentsand/or configurations discussed.

FIG. 1 is a teleoperated interventional system, in accordance withembodiments of the present disclosure.

FIG. 2 illustrates an interventional instrument system utilizing aspectsof the present disclosure.

FIG. 3 illustrates a distal end of the interventional instrument systemof FIG. 2 with an extended interventional tool.

FIG. 4 illustrates an anatomic model image with a distal end of aninterventional instrument at a deployment location.

FIG. 5 is a view of a portion of the FIG. 4.

FIG. 6 illustrates an anatomic model image with a distal end of aninterventional instrument at a revised deployment location based onsensor feedback.

FIG. 7 is a flowchart describing a method for identifying a planneddeployment location for an interventional instrument.

FIG. 8 is a flowchart describing a method for revising the planneddeployment location based upon sensor feedback.

FIG. 9 is a flowchart describing a method for identifying the targetstructure using the imaging systems.

FIGS. 10A, 10B, and 11 are illustrations of the method of FIG. 9.

DETAILED DESCRIPTION

In the following detailed description of the aspects of the invention,numerous specific details are set forth in order to provide a thoroughunderstanding of the disclosed embodiments. However, it will be obviousto one skilled in the art that the embodiments of this disclosure may bepracticed without these specific details. In other instances well knownmethods, procedures, components, and circuits have not been described indetail so as not to unnecessarily obscure aspects of the embodiments ofthe invention. And, to avoid needless descriptive repetition, one ormore components or actions described in accordance with one illustrativeembodiment can be used or omitted as applicable from other illustrativeembodiments.

The embodiments below will describe various instruments and portions ofinstruments in terms of their state in three-dimensional space. As usedherein, the term “position” refers to the location of an object or aportion of an object in a three-dimensional space (e.g., three degreesof translational freedom along Cartesian X, Y, Z coordinates). As usedherein, the term “orientation” refers to the rotational placement of anobject or a portion of an object (three degrees of rotationalfreedom—e.g., roll, pitch, and yaw). As used herein, the term “pose”refers to the position of an object or a portion of an object in atleast one degree of translational freedom and to the orientation of thatobject or portion of the object in at least one degree of rotationalfreedom (up to six total degrees of freedom). As used herein, the term“shape” refers to a set of poses, positions, or orientations measuredalong an object.

Referring to FIG. 1 of the drawings, a teleoperated interventionalsystem for use in, for example, surgical, diagnostic, therapeutic, orbiopsy procedures, is generally indicated by the reference numeral 100.As shown in FIG. 1, the teleoperated system 100 generally includes aninterventional manipulator assembly 102 for operating an interventionalinstrument 104 in performing various procedures on the patient P. Theassembly 102 is mounted to or near an operating table O. A masterassembly 106 allows the surgeon S to view the surgical site and tocontrol the slave manipulator assembly 102.

The master assembly 106 may be located at a surgeon's console C which isusually located in the same room as operating table O. However, itshould be understood that the surgeon S can be located in a differentroom or a completely different building from the patient P. Masterassembly 106 generally includes an optional support 108 and one or morecontrol device(s) 112 for controlling the manipulator assemblies 102.The control device(s) 112 may include any number of a variety of inputdevices, such as joysticks, trackballs, data gloves, trigger-guns,hand-operated controllers, voice recognition devices, body motion orpresence sensors, or the like. In some embodiments, the controldevice(s) 112 will be provided with the same degrees of freedom as theassociated interventional instruments 104 to provide the surgeon withtelepresence, or the perception that the control device(s) 112 areintegral with the instruments 104 so that the surgeon has a strong senseof directly controlling instruments 104. In other embodiments, thecontrol device(s) 112 may have more or fewer degrees of freedom than theassociated interventional instruments 104 and still provide the surgeonwith telepresence. In some embodiments, the control device(s) 112 aremanual input devices which move with six degrees of freedom, and whichmay also include an actuatable handle for actuating instruments (forexample, for closing grasping jaws, applying an electrical potential toan electrode, delivering a medicinal treatment, or the like).

In alternative embodiments, the teleoperated system may include morethan one slave manipulator assembly and/or more than one masterassembly. The exact number of manipulator assemblies will depend on thesurgical procedure and the space constraints within the operating room,among other factors. The master assemblies may be collocated, or theymay be positioned in separate locations. Multiple master assembliesallow more than one operator to control one or more slave manipulatorassemblies in various combinations.

An optional visualization system 110 may include an endoscope systemsuch that a concurrent (real-time) image of the surgical site isprovided to surgeon console C. The concurrent image may be, for example,a two- or three-dimensional image captured by an endoscopic probepositioned within the surgical site. In this embodiment, thevisualization system 110 includes endoscopic components that may beintegrally or removably coupled to the interventional instrument 104. Inalternative embodiments, however, a separate endoscope attached to aseparate manipulator assembly may be used to image the surgical site.Alternatively, a separate endoscope assembly may be directly operated bya user, without teleoperational control. The endoscope assembly mayinclude active steering (e.g., via teleoperated steering wires) orpassive steering (e.g., via guide wires or direct user guidance). Thevisualization system 110 may be implemented as hardware, firmware,software, or a combination thereof, which interacts with or is otherwiseexecuted by one or more computer processors, which may include theprocessor(s) of a control system 116.

A display system 111 may display an image of the surgical site andinterventional instruments captured by the visualization system 110. Thedisplay 111 and the master control device(s) 112 may be oriented suchthat the relative positions of the imaging device in the scope assemblyand the interventional instruments are similar to the relative positionsof the surgeon's eyes and hand(s) so the operator can manipulate theinterventional instrument 104 and the master control device(s) 112 as ifviewing the workspace in substantially true presence. True presencemeans that the displayed tissue image appears to an operator as if theoperator was physically present at the imager location and directlyviewing the tissue from the imager's perspective.

Alternatively or additionally, display system 111 may present images ofthe surgical site recorded and/or modeled preoperatively using imagingtechnology such as computerized tomography (CT), magnetic resonanceimaging (MRI), fluoroscopy, thermography, ultrasound, optical coherencetomography (OCT), thermal imaging, impedance imaging, laser imaging,nanotube X-ray imaging, or the like. The presented preoperative imagesmay include two-dimensional, three-dimensional, or four-dimensional(including e.g., time based or velocity based information) images.

In some embodiments, the display system 111 may display a virtualvisualization image in which the actual location of the interventionalinstrument is registered (e.g., dynamically referenced) withpreoperative or concurrent images from the modeled anatomy to presentthe surgeon S with a virtual image of the internal surgical site at thelocation of the tip of the surgical instrument.

In other embodiments, the display system 111 may display a virtualvisualization image in which the actual location of the interventionalinstrument is registered with prior images (including preoperativelyrecorded images) or concurrent images from the modeled anatomy topresent the surgeon S with a virtual image of an interventionalinstrument at the surgical site. An image of a portion of theinterventional instrument may be superimposed on the virtual image toassist the surgeon controlling the interventional instrument.

In FIG. 1, a control system 116 includes at least one processor (notshown), and typically a plurality of processors, for effecting controlbetween the slave surgical manipulator assembly 102, the master assembly106, the visualization system 110, and the display system 11. Thecontrol system 116 also includes programmed instructions (e.g., acomputer-readable medium storing the instructions) to implement some orall of the methods described herein. While control system 116 is shownas a single block in the simplified schematic of FIG. 1, the system maycomprise a number of data processing circuits (e.g., on the slavesurgical manipulator assembly 102 and/or on the master assembly 106),with at least a portion of the processing optionally being performedadjacent the slave surgical manipulator assembly, a portion beingperformed at the master assembly, and the like. Any of a wide variety ofcentralized or distributed data processing architectures may beemployed. Similarly, the programmed instructions may be implemented as anumber of separate programs or subroutines, or they may be integratedinto a number of other aspects of the teleoperational systems describedherein. In one embodiment, control system 116 supports wirelesscommunication protocols such as Bluetooth, IrDA, HomeRF, IEEE 802.11.DECT, and Wireless Telemetry.

In some embodiments, control system 116 may include one or more servocontrollers to provide force and torque feedback from the interventionalinstruments 104 to one or more corresponding servomotors for the controldevice(s) 112. The servo controller(s) may also transmit signalsinstructing manipulator assembly 102 to move instruments which extendinto an internal surgical site within the patient body via openings inthe body. Any suitable conventional or specialized servo controller maybe used. A servo controller may be separate from, or integrated with,manipulator assembly 102. In some embodiments, the servo controller andmanipulator assembly are provided as part of a manipulator arm cartpositioned adjacent to the patient's body.

Each manipulator assembly 102 supports a interventional instrument 104and may comprise a kinematic structure of one or more non-servocontrolled links (e.g., one or more links that may be manuallypositioned and locked in place, generally referred to as a set-upstructure) and a teleoperated manipulator. The teleoperated manipulatorassembly 102 is driven by a plurality of actuators (e.g., motors). Thesemotors actively move the teleoperated manipulators in response tocommands from the control system 116. The motors are further coupled tothe interventional instrument so as to advance the interventionalinstrument into a naturally or surgically created anatomical orifice andto move the distal end of the interventional instrument in multipledegrees of freedom, which may include three degrees of linear motion(e.g., linear motion along the X, Y, Z Cartesian axes) and three degreesof rotational motion (e.g., rotation about the X, Y, Z Cartesian axes).Additionally, the motors can be used to actuate an articulable endeffector of the instrument for grasping tissue in the jaws of a biopsydevice or the like.

FIG. 2 illustrates a minimally invasive system 200 utilizing aspects ofthe present disclosure. The system 200 may be incorporated into ateleoperated interventional system, such as system 100. Alternatively,the system 200 may be used for exploratory procedures or in proceduresinvolving traditional manually operated interventional instruments, suchas laparoscopic instruments. The system 200 includes a catheter system202 (e.g., part of the instrument 104) coupled by an interface unit 204to a tracking system 206. A navigation system 210 (e.g., part of thecontrol system 116) processes information from a virtual visualizationsystem 208, one or more imaging systems 212, and/or the tracking system206 to generate one or more image displays on a display system 214(e.g., part of the display system 111). The system 200 may furtherinclude optional operation and support systems (not shown) such asillumination systems, steering control systems, irrigation systems,and/or suction systems.

The catheter system 202 includes an elongated flexible body 216 having aproximal end 217 and a distal end 218. A channel 219 extends within theflexible body 216. In one embodiment, the flexible body 216 has anapproximately 3 mm outer diameter. Other flexible body outer diametersmay be larger or smaller. The catheter system 202 optionally includes asensor system which includes a position sensor system 220 (e.g., anelectromagnetic (EM) sensor system) and/or a shape sensor system 222 fordetermining the position, orientation, speed, pose, and/or shape of thecatheter tip at distal end 218 and/or of one or more segments 224 alongthe body 216. The entire length of the body 216, between the distal end218 and the proximal end 217 may be effectively divided into thesegments 224. The position sensor system 220 and the shape sensor system222 interface with the tracking system 206. The tracking system 206 maybe implemented as hardware, firmware, software or a combination thereofwhich interact with or are otherwise executed by one or more computerprocessors, which may include the processors of a control system 116.

The position sensor system 220 may be an EM sensor system that includesone or more conductive coils that may be subjected to an externallygenerated electromagnetic field. Each coil of the EM sensor system 220then produces an induced electrical signal having characteristics thatdepend on the position and orientation of the coil relative to theexternally generated electromagnetic field. In one embodiment, the EMsensor system may be configured and positioned to measure six degrees offreedom. e.g., three position coordinates X, Y, Z and three orientationangles indicating pitch, yaw, and roll of a base point. Furtherdescription of an EM sensor system is provided in U.S. Pat. No.6,380,732, filed Aug. 11, 1999, disclosing “Six-Degree of FreedomTracking System Having a Passive Transponder on the Object BeingTracked.” which is incorporated by reference herein in its entirety.

The shape sensor system 222 includes an optical fiber aligned with theflexible body 216 (e.g., provided within an interior channel (not shown)or mounted externally). The tracking system 206 may be coupled to aproximal end of the optical fiber. In one embodiment, the optical fiberhas a diameter of approximately 200 μm. In other embodiments, thedimensions may be larger or smaller.

The optical fiber of the shape sensor system 222 forms a fiber opticbend sensor for determining the shape of the catheter system 202. In onealternative, optical fibers including Fiber Bragg Gratings (FBGs) areused to provide strain measurements in structures in one or moredimensions. Various systems and methods for monitoring the shape andrelative position of an optical fiber in three dimensions are describedin U.S. patent application Ser. No. 11/180,389, filed Jul. 13, 2005,disclosing “Fiber optic position and shape sensing device and methodrelating thereto;” U.S. Provisional Pat. App. No. 60/588,336, filed onJul. 16, 2004, disclosing “Fiber-optic shape and relative positionsensing;” and U.S. Pat. No. 6,389,187, filed on Jun. 17, 1998,disclosing “Optical Fibre Bend Sensor.” which are incorporated byreference herein in their entireties. In other alternatives, sensorsemploying other strain sensing techniques such as Rayleigh scattering,Raman scattering, Brillouin scattering, and Fluorescence scattering maybe suitable. In other alternative embodiments, the shape of the cathetermay be determined using other techniques. For example, if the history ofthe catheter's distal tip pose is stored for an interval of time that issmaller than the period for refreshing the navigation display or foralternating motion (e.g., inhalation and exhalation), the pose historycan be used to reconstruct the shape of the device over the interval oftime. As another example, historical pose, position, or orientation datamay be stored for a known point of an instrument along a cycle ofalternating motion, such as breathing. This stored data may be used todevelop shape information about the catheter. Alternatively, a series ofpositional sensors, such as EM sensors, positioned along the cathetercan be used for shape sensing. Alternatively, a history of data from apositional sensor, such as an EM sensor, on the instrument during aprocedure may be used to represent the shape of the instrument,particularly if an anatomical passageway is generally static.Alternatively, a wireless device with position or orientation controlledby an external magnetic field may be used for shape sensing. The historyof its position may be used to determine a shape for the navigatedpassageways.

In this embodiment, the optical fiber may include multiple cores withina single cladding. Each core may be single-mode with sufficient distanceand cladding separating the cores such that the light in each core doesnot interact significantly with the light carried in other cores. Inother embodiments, the number of cores may vary or each core may becontained in a separate optical fiber.

In some embodiments, an array of FBG's is provided within each core.Each FBG comprises a series of modulations of the core's refractiveindex so as to generate a spatial periodicity in the refraction index.The spacing may be chosen so that the partial reflections from eachindex change add coherently for a narrow band of wavelengths, andtherefore reflect only this narrow band of wavelengths while passingthrough a much broader band. During fabrication of the FBG's, themodulations are spaced by a known distance, thereby causing reflectionof a known band of wavelengths. However, when a strain is induced on thefiber core, the spacing of the modulations will change, depending on theamount of strain in the core. Alternatively, backscatter or otheroptical phenomena that vary with bending of the optical fiber can beused to determine strain within each core.

Thus, to measure strain, light is sent down the fiber, andcharacteristics of the returning light are measured. For example, FBG'sproduce a reflected wavelength that is a function of the strain on thefiber and its temperature. This FBG technology is commercially availablefrom a variety of sources, such as Smart Fibres Ltd. of Bracknell,England. Use of FBG technology in position sensors for teleoperationalsurgery is described in U.S. Pat. No. 7,930,065, filed Jul. 20, 2006,disclosing “Robotic Surgery System Including Position Sensors UsingFiber Bragg Gratings,” which is incorporated by reference herein in itsentirety.

When applied to a multicore fiber, bending of the optical fiber inducesstrain on the cores that can be measured by monitoring the wavelengthshifts in each core. By having two or more cores disposed off-axis inthe fiber, bending of the fiber induces different strains on each of thecores. These strains are a function of the local degree of bending ofthe fiber. For example, regions of the cores containing FBG's, iflocated at points where the fiber is bent, can thereby be used todetermine the amount of bending at those points. These data, combinedwith the known spacings of the FBG regions, can be used to reconstructthe shape of the fiber. Such a system has been described by LunaInnovations. Inc. of Blacksburg, Va.

As described, the optical fiber may be used to monitor the shape of atleast a portion of the catheter system 202. More specifically, lightpassing through the optical fiber is processed by the tracking system206 for detecting the shape of the catheter system 202 and for utilizingthat information to assist in surgical procedures. The tracking system206 may include a detection system for generating and detecting thelight used for determining the shape of the catheter system 202. Thisinformation, in turn, in can be used to determine other relatedvariables, such as velocity and acceleration of the parts of aninterventional instrument. The sensing may be limited only to thedegrees of freedom that are actuated by the teleoperational system, ormay be applied to both passive (e.g., unactuated bending of the rigidmembers between joints) and active (e.g., actuated movement of theinstrument) degrees of freedom.

The flexible body 216 may optionally house one or more image captureprobes 226 that transmit captured image data to the imaging system(s)212. For example, the image capture probe 226 may be an endoscopic probeincluding a tip portion with a stereoscopic or monoscopic cameradisposed near the distal end 218 of the flexible body 216 for capturingimages (including video images) that are transmitted to the imagingsystem 212. The image capture probe 226 may include a cable coupled tothe camera for transmitting the captured image data. Alternatively, theimage capture instrument may be a fiber-optic bundle, such as afiberscope, that couples to the imaging system. The image captureinstrument may be single or multi-spectral, for example capturing imagedata in the visible spectrum, or capturing image data in the visible andinfrared or ultraviolet spectrums.

Additionally or alternatively, the image capture probe 226 may be asensor probe for use with a reflective imaging technology such asultrasound or optical coherence tomography (OCT). For example, the probemay include a transmitter and receiver arrangement, such as anultrasound transducer. The ultrasonic transducer can be mounted at anend of an elongated shaft. Such a source can be used to obtain apreoperative or intraoperative two-dimensional or three-dimensionalimage, or model, of the anatomic region where the interventionalprocedure is to be performed. As a two-dimensional source, theultrasonic transducer can be used to obtain a single ultrasound image.As a three-dimensional source it can be used to obtain a plurality ofspaced ultrasonic images, or cuts, thereby to provide sufficientinformation for construction of a three-dimensional model. Accordingly,it can be arranged to move, including rotate, within an anatomic site tocapture such images, or cuts. This can typically be achieved, forexample, in accordance with a pre-programmed sequence for moving theultrasound transducer by teleoperational control, manual movement of theultrasound transducer, or the like.

The body 216 may also house cables, linkages, or other steering controls(not shown) that extend between the interface 204 and the tip distal end218 to controllably bend or turn the distal end 218 as shown for exampleby the dotted line versions of the distal end. The catheter system maybe steerable or, alternatively, may be non-steerable with no integratedmechanism for operator control of the instrument bending. The flexiblebody 216 may further house control mechanisms (not shown) for operatinga surgical end effector or another working distal part that ismanipulable for a medical function, e.g., for effecting a predeterminedtreatment of a target tissue. For instance, some end effectors have asingle working member such as a scalpel, a blade, an optical fiber, oran electrode. Other end effectors may include pair or plurality ofworking members such as forceps, graspers, scissors, or clip appliers,for example. Examples of electrically activated end effectors includeelectrosurgical electrodes, transducers, sensors, and the like.

As shown in greater detail in FIG. 3, interventional tool(s) 228 forsuch procedures as surgery, biopsy, ablation, illumination, irrigation,or suction can be deployed through the channel 219 of the and used at atarget location within the anatomy. The intervertebral tool 228 may alsobe the image capture probe. The tool 228 may be advanced from theopening of the channel 219 to perform the procedure and then retractedback into the channel when the procedure is complete. The interventionaltool 228 may be removed from the proximal end 217 of the catheterflexible body or from another optional instrument port (not shown) alongthe flexible body.

The virtual visualization system 208 provides navigation assistance tothe catheter system 202. Virtual navigation using the virtualvisualization system is based upon reference to an acquired datasetassociated with the three dimensional structure of the anatomicalpassageways. More specifically, the virtual visualization system 208processes images of the surgical site recorded and/or modeled usingimaging technology such as computerized tomography (CT), magneticresonance imaging (MRI), fluoroscopy, thermography, ultrasound, opticalcoherence tomography (OCT), thermal imaging, impedance imaging, laserimaging, nanotube X-ray imaging, or the like. Software is used toconvert the recorded images into a two dimensional or three dimensionalmodel of a partial or an entire anatomical organ or anatomical region.The model describes the various locations and shapes of the passagewaysand their connectivity. The images used to generate the model may berecorded preoperatively or intra-operatively during a clinicalprocedure. In an alternative embodiment, a virtual visualization systemmay use standard models (i.e., not patient specific) or hybrids of astandard model and patient specific data. The model and any virtualimages generated by the model may represent the static posture of adeformable anatomic region during one or more phases of motion (e.g.,during an inspiration/expiration cycle of a lung).

During a virtual navigation procedure, the sensor systems may be used tocompute an approximate location of the instrument with respect to thepatient anatomy. The location can be used to produce both macro-leveltracking images of the patient anatomy and virtual internal images ofthe patient anatomy. Various systems for using fiber optic sensors toregister and display an interventional implement together withpreoperatively recorded surgical images, such as those from a virtualvisualization system, are known. For example U.S. patent applicationSer. No. 13/107,562, filed May 13, 2011, disclosing, “Medical SystemProviding Dynamic Registration of a Model of an Anatomical Structure forImage-Guided Surgery.” which is incorporated by reference herein in itsentirety, discloses one such system.

The navigation system 210, as part of the control system 116, processesinformation from the virtual visualization system 208, the one or moreimaging systems 212, and/or the tracking system 206 to determine anavigational path for the interventional instrument through theanatomical system to the target anatomical structure. The navigationsystem 210 may also monitor the navigational path of the interventionalinstrument as it moves through the anatomical system to a targetstructure. The navigation system 210 includes a planning module 211 thatallows a clinician to locate a target anatomical structure (e.g., atumor) in the anatomical model prepared by the virtual visualizationsystem 208 and to identify a navigational path through anatomicalpassageways to reach the target structure to perform an interventionalprocedure (e.g., a biopsy) with the interventional instrument. Thetarget localization and navigational path determination may be automatedsuch that the navigation system identifies one or more navigationalpaths. Alternatively, a clinician may determine the navigational pathfrom the anatomic model and optionally communicate the selected path tothe navigational system. In still another alternative, the planningmodule uses a hybrid automated/clinician selected navigational pathdetermination in which the clinician may modify a system planned path orin which the clinician may enter parameters such as anatomical areas toavoid or instrument limitations that constrain the planned navigationalpath suggested by the planning module 212.

The navigation planning module generates or allows the clinician toselect a planned deployment location within an anatomical passageway forparking a distal end of the interventional instrument to conduct theinterventional procedure. Referring now to FIG. 4, a virtual image 300of target structure 302, such as a tumor, and nearby anatomicpassageways 304 is depicted. The passageways include passageway walls306 and carina 308. In this embodiment, the anatomic passageways arebronchial passageways of the lung, but the systems and methods of thisdisclosure may be suitable for use in other natural or surgicallycreated passageways in anatomical systems such as the colon, theintestines, the kidneys, the heart, or the circulatory system. Aninterventional instrument with a flexible body 309 (substantiallysimilar to flexible body 216) and an extended interventional tool 310are shown. In one embodiment, a navigation planning module identifiesthe planned deployment location as a location 312 along a wall of ananatomic passageway closest to or nearby to the target structure.However, selecting the deployment location entirely on the basis ofproximity to the target structure may result in a selected deploymentlocation that is inaccessible or not easily accessible by theinterventional instrument. For example, the interventional instrumentmay be incapable of bending sufficiently within the passageway to accessthe proximity based deployment location. Additionally the selecteddeployment location or the navigational path to the deployment locationmay not consider anatomical constraints, such as scar or diseased tissueto avoid.

In other embodiments, a navigation planning module selects thedeployment location based upon a plurality of factors, which in someinstances may be procedural characteristics, such as the distance to thetarget structure, and/or the position of the target structure relativeto other anatomic features. In other embodiments, the navigationplanning module may additionally or alternatively receive and useinformation about the operational capability of the interventionalinstrument to determine a deployment location. For example, informationpertaining to the bending capability of the instrument may beconsidered, such as the flexibility and elasticity of the cathetermaterial, any preformed shape characteristics of the catheter or toolspassed through the channel of the catheter, the steerability of thedistal end of the catheter or tool (e.g., the degree to which the distaltip of the catheter may be curved relative to the main axis of thecatheter), and the curvature along the length of the catheter. Othercharacteristics of the interventional instrument may also be used todetermine the deployment location including the diameter of thecatheter, the diameter of the tool, the trajectory of the tool whenextended from the catheter (e.g., curved, straight), the movement of thetool (e.g., sweeping, spinning, linear), the maximum angulation of theaxis of the tool versus the axis of the catheter, the maximum length thetool can be extended from the catheter, and any anchoring structures atthe distal tip of the catheter providing frictional contact with thepassageway wall. The information pertaining to the bending capabilityand/or the information related to the characteristics of theinterventional instrument are exemplary factors that can be used todetermine the operational capability of the interventional instrumentwithin the anatomical passageways.

The navigation planning module may also or alternatively receive and useinformation about the patient anatomy to determine a deploymentlocation. Such information may include, for example, the location of thecarinas of the anatomical passageways nearest to the target structureand the size of the passageways nearest to the target structure. Otheranatomic information may include the elasticity of the anatomicalpassageways including the impact that any disease processes may have hadon the elasticity of the passageways. The navigation planning model mayalso consider the surrounding anatomic tissue to, for example, select adeployment location that reduces the risk to surrounding tissue. As oneexample, a deployment location away from the perimeter of a lung may beselected to avoid the risk of puncturing the lung with the deployedtool. The navigation planning model may also consider the anatomy of thetarget structure to access a preferred location of the target structure.For example, the deployment location may be selected such that a biopsytool avoids a calcified part of a tumor.

The navigation planning module may also consider information about therelationship between the interventional instrument and the patientanatomy such as the distance of the target structure from the end of thecatheter. Referring to FIG. 5, the navigation planning module may alsoconsider the angle of approach 320 between the interventional tool andthe passageway wall. For example, an approach angle of 90° mayimpracticable due to the small size of the passageway and thebendability of the distal tip of the catheter. An approach angle of 1°may also be unsuitable because of the risk that the interventional toolmay graze the surface of the passageway wall without penetrating. Forthese reasons, the navigation planning module may select a deploymentlocation such that the approach angle is between approximately 30° and90°.

Referring again to FIG. 4, after the navigation planning moduleevaluates the factors related to the interventional instrument and thepatient anatomy, a deployment location 314 on the wall of an anatomicpassageway is identified. Optionally, the navigation planning module mayprovide a suggested navigational path to the deployment location. Theclinician can then direct the distal end of the interventionalinstrument to the deployment location. The clinician may manuallycontrol the navigation of the interventional instrument based uponvirtual or real image guidance. Alternatively, the clinician canteleoperationally control the navigation of the interventionalinstrument or allow computer-controlled navigation of the interventionalinstrument along the suggested navigational path. After the distal endof the interventional instrument is positioned at the deploymentlocation, the interventional tool is extended from the catheter, throughthe passageway wall and into contact with the target structure. In somecircumstances, for example when a target structure is located within ananatomic passageway, the deployment location may be located within thelumen of the passageway, rather than on the wall of the passageway. Forexample when the target structure is within the passageway, thedeployment location may be on a surface of the target structure.

FIG. 7 is a flowchart describing a method 400 used by the navigationplanning module for identifying a planned deployment location for aninterventional instrument. At 402, a model of an anatomic structure isreceived. The anatomic structure includes a plurality of anatomicpassageways which are illustrated by the model. The model is formed fromtwo or three dimensional images of the surgical site recorded and/ormodeled preoperatively or interoperatively using imaging technology suchas CT, MRI, fluoroscopy, thermography, ultrasound, OCT, thermal imaging,impedance imaging, laser imaging, nanotube X-ray imaging, or the like.Receipt of the model may include receiving information about the patientanatomy derived from the model, from user inputs describing the patientanatomy, or from other reference sources. Such information about thepatient anatomy may include, for example, the closest location(s) withinan anatomic passageway(s) to the target structure, the location of thecarinas of the anatomical passageways nearest to the target structure,and the size of the passageways nearest to the target structure. Otheranatomic information may include the elasticity of the anatomicalpassageways, the anatomy of the target structure to access a preferredlocation of the target structure, and the type of surrounding tissue andany risk associated with contacting the surrounding tissue.

At 404, a location of a target structure (e.g., a tumor) is identifiedin the model. Identifying the target structure may include determiningor receiving information about the target structure from the model, fromuser inputs describing the target structure, or from other referencesources. Such information about the target structure may include, forexample, the shape of the target structure, the one or more substancesthat form the target structure, and the location of the surfaces of thetarget structure relative to nearby anatomic passageways.

At 406, information about the operational capability of theinterventional instrument is received. The information received todetermine the operational capability of the interventional instrumentmay include, for example, information pertaining to the bendingcapability of the instrument such as the flexibility and elasticity ofthe catheter material, any preformed shape characteristics of thecatheter or tools passed through the channel of the catheter, thesteerability of the distal end of the catheter or tool, and thecurvature along the length of the catheter. The operational capabilityof the interventional instrument may also be determined fromcharacteristics of the interventional instrument such as the diameter ofthe catheter, the diameter of the tool, the maximum angulation of theaxis of the tool versus the axis of the catheter, the maximum length thetool can be extended from the catheter, and any anchoring structures atthe distal tip of the catheter providing frictional contact with thepassageway wall.

At 408, a planned deployment location for the interventional instrumentis located. The planned deployment location may be marked on the modelof the plurality of passageways. The planned deployment location can beselected based upon the instrument operational capability information,the target structure information, the patient anatomy information, or acombination of the types of information. The selected deploymentlocation may be at a point in an anatomic passageway nearest to thetarget structure. However, in many patients a nearest point deploymentlocation may be impossible for the distal end of the interventionalinstrument to reach because the instrument has insufficient bendcapability within the size and elasticity constraints of the selectedanatomic passageway. A more suitable deployment location may be at apoint on an anatomic passageway wall where the interventional instrumenthas an approach angle to the passageway wall that is within the bendingcapability of the instrument. For example, if the interventionalinstrument has an inflexible distal end that permits little or nobending, a suitable deployment location may be at a carina near thetarget structure. At the carina the interventional instrument may bedeployed at an approximately 90° approach angle to the passageway wallwith minimal bending of the distal end of the instrument. As anotherexample, the navigation planning module may select a deployment locationsuch that the approach angle is between approximately 30° and 90°. Whenselecting a deployment location, the planning system also confirms thatthe interventional tool is capable of extending from the catheter asufficient distance to reach the target structure to perform theinterventional procedure.

As described, the planned deployment location may be located based onthe analysis of the instrument operational capability, the targetstructure, and the patient anatomy. Alternatively or in combination withthe system assessment, the planned deployment location may be identifiedby a clinician and communicated to the navigation planning module tolocate or mark the clinician-identified planned deployment location inthe model. When the navigation planning module receives theclinician-identified planned deployment location, the module may compareit with the system-identified deployment location. A visual or audiblefeedback cue may be issued if the clinician-identified deploymentlocation is objectionable (e.g., “The chosen biopsy needle is not longenough to reach the target from this deployment location.”).

Optionally, the navigation planning module identifies multiple electivedeployment locations. The elective deployment locations may be coded(e.g., with color on the display) to provide information about therelative quality of the elective deployment locations for deploying theinterventional instrument to perform the procedure. A clinician mayselect one of elective deployment locations to be the planned deploymentlocation. Alternatively, more than one planned deployment location maybe selected from the elective deployment locations, allowing theinterventional procedure to be performed from different approaches. Theselection of elective deployment locations may also occur during theinterventional procedure if the clinician determines that an initiallychosen deployment location is unsuitable.

To further refine the step of identifying the target structure, one ormore of the imaging systems 212 may be used to gather additionalinformation about the location of the target structure after theinterventional instrument has been deployed to the identified deploymentlocation or the general vicinity thereof. Referring now to FIG. 6, thevirtual image 300 of target structure 302 and nearby anatomicpassageways 304 is again depicted. The distal end of the flexible body309 is first positioned at a target confirmation location such aslocation 312. The image capture probe 226 is operated to determine ifthe target structure 302 is in the expected position relative to thetarget confirmation location. If the target structure 302 is not foundor not in the expected position, the flexible body and image captureprobe can be moved around until the target structure is located. Whenthe target structure is located, the location of the distal end of theflexible body 309 or image capture probe is recorded at a new location322. The navigation planning module 211 then updates the location of thetarget structure 302′. With the new location of the target structureidentified, the operational capability information for theinterventional instrument is used to identify a revised planneddeployment location 324. For example, the navigation planning module mayuse the difference between locations 312 and 322 to update location 314to location 322 and to update the location of the target structure 302to 302′. In one embodiment, the image capture probe uses one or moresensors for reflective imaging technology such as ultrasound or OCT torefine the location of the target structure. Alternatively, othernon-imaging sensors may be used to identify the location of the targetstructure.

FIG. 8 is a flowchart describing a method 450 used by the navigationplanning module for revising a planned deployment location for aninterventional instrument. At 452, information is received from theimage capture probe after the probe has been operated at the initialplanned deployment location or at a target confirmation location. At454, a revised location of the target structure is identified using theinformation received from the image capture probe. At 456, a revisedplanned deployment location is identified in the model of the pluralityof passageways.

An alternative method 500 for identifying the target structure using theimaging systems 212 is described at FIG. 9 and illustrated at FIGS. 10A,10B, and 11. The method 500 may be performed to identify an initialinterventional deployment location or may be used to identify a reviseddeployment location as described below.

At 502, the catheter is navigated to a passageway location such aslocation 312 or 314 with the guidance of the navigation systemincluding, for example, visual. EM or shape sensor information. Aconfirmation from the clinician or from the interventional instrumentmay be provided when the catheter has reached the location. At 504, animaging probe (e.g., an ultrasound probe) is inserted through thecatheter and the movement of the imaging probe relative to a portion ofthe catheter (e.g., the catheter tip) is tracked. In some embodiments,the same imaging probe (e.g., the same ultrasound probe) could also beused during the navigation of 502. The movement of the imaging probe maybe tracked, for example using a positional sensor such as a 5 or 6degree of freedom EM sensor. Alternatively, the movement may be trackedusing an insertion sensor such as an encoder located outside the patientanatomy. Alternatively, the movement may be tracked by engaging astepping motor to control the insertion motion of the imaging probe.

At 506, the roll angle of an imaging coordinate system for the imagingprobe is determined with respect to the catheter. For example, the rollangle may be determined using a roll alignment feature of the axialimaging probe and the catheter (e.g. a key system). Alternatively, aroll sensor located outside of the patient anatomy may be used. In stillanother alternative, the roll angle may be determined by viewing one ormore markers or other features with a known angle relative to thecatheter in the image recorded by the imaging probe. For example, thefeature or marker may be located on the circumference of the catheterand have a contrast (e.g. an ultrasound contrast) to the catheter.

At 508, the catheter and/or the imaging probe is moved around in theanatomic passageways to detect the target structure in the imagegenerated by the probe. At 510, after the target structure is detectedby the imaging probe, a clinician may identify the target structure inthe image using a pointing device at a pointer location. The image (e.g.an ultrasound image) may be generated by a scan that is gated forrespiratory and/or cardiac cycles. A three-dimensional image may beconstructed from two-dimensional scans.

At 512, the pointer location is transformed to the catheter coordinatesystem or to the patient coordinate system (which has been previouslyregistered to the catheter coordinate system). At 514, the pointerlocation can be used to apply an offset to the location of the targetstructure identified in the preoperative anatomic model. A revisedtarget structure location is computed based upon the offset. The imagingprobe may then be removed and a biopsy tool or other interventional toolmay be inserted through the catheter to perform a procedure (e.g., abiopsy) at the revised location.

FIG. 10A illustrates a patient reference frame indicated with thecoordinate references X_(P), Y_(P), and Z_(P). Also illustrated is acatheter C having a catheter tip reference frame indicated with thecoordinate references X_(C), Y_(C), and Z_(C). A target location P_(P)is shown in the patient reference frame. A target location Q accordingto the pre-op model is shown. A correction vector O between the targetlocations Q and P_(P) is also shown. A tracked insertion length L fromthe catheter tip is shown.

FIG. 10B is an ultrasound image having an image reference frameindicated with the coordinate references X_(I), Y_(I), and Z_(I). Atarget location P_(I) is shown in the image reference frame.

FIG. 11 illustrates a biopsy procedure according to P_(P) instead of Q,using biopsy instrument B.

Although the systems and methods of this disclosure have been describedfor use in the connected bronchial passageways of the lung, they arealso suited for navigation and treatment of other tissues, via naturalor surgically created connected passageways, in any of a variety ofanatomical systems including the colon, the intestines, the kidneys, thebrain, the heart, the circulatory system, or the like. The methods andembodiments of this disclosure are also suitable for non-interventionalapplications.

One or more elements in embodiments of the invention may be implementedin software to execute on a processor of a computer system such ascontrol system 116. When implemented in software, the elements of theembodiments of the invention are essentially the code segments toperform the necessary tasks. The program or code segments can be storedin a processor readable storage medium or device that may have beendownloaded by way of a computer data signal embodied in a carrier waveover a transmission medium or a communication link. The processorreadable storage device may include any medium that can storeinformation including an optical medium, semiconductor medium, andmagnetic medium. Processor readable storage device examples include anelectronic circuit; a semiconductor device, a semiconductor memorydevice, a read only memory (ROM), a flash memory, an erasableprogrammable read only memory (EPROM); a floppy diskette, a CD-ROM, anoptical disk, a hard disk, or other storage device. The code segmentsmay be downloaded via computer networks such as the Internet, Intranet,etc.

Note that the processes and displays presented may not inherently berelated to any particular computer or other apparatus. The requiredstructure for a variety of these systems will appear as elements in theclaims. In addition, the embodiments of the invention are not describedwith reference to any particular programming language. It will beappreciated that a variety of programming languages may be used toimplement the teachings of the invention as described herein.

While certain exemplary embodiments of the invention have been describedand shown in the accompanying drawings, it is to be understood that suchembodiments are merely illustrative of and not restrictive on the broadinvention, and that the embodiments of the invention not be limited tothe specific constructions and arrangements shown and described, sincevarious other modifications may occur to those ordinarily skilled in theart.

1-20. (canceled)
 21. A system for performing an interventional procedure, the system comprising: an interventional instrument comprising a catheter and an interventional tool extendable from the catheter; and a control system comprising a processor and a memory comprising machine-readable instructions that, when executed by the processor, cause the control system to: receive a model of an anatomic structure, the anatomic structure including a plurality of passageways; identify a target structure in the model; receive information about a maximum extension length the interventional tool can be extended relative to a distal tip of the catheter; and based upon the received information about the maximum extension length, identify a planned deployment location for positioning the distal tip of the catheter to perform the interventional procedure on the target structure.
 22. The system of claim 21, wherein the interventional tool comprises an imaging probe.
 23. The system of claim 22, wherein the imaging probe comprises an ultrasound probe.
 24. The system of claim 22, wherein the imaging probe comprises an optical coherence tomography probe.
 25. The system of claim 21, wherein the machine-readable instructions, when executed by the processor, further cause the control system to track movement of the interventional tool relative to the catheter using an insertion sensor.
 26. The system of claim 25, wherein the insertion sensor comprises an encoder.
 27. The system of claim 21, wherein the machine-readable instructions, when executed by the processor, further cause the control system to track movement of the interventional tool relative to the catheter based on a motor used to control insertion of the interventional tool.
 28. The system of claim 21, wherein the machine-readable instructions, when executed by the processor, further cause the control system to track movement of the interventional tool relative to the catheter using an electromagnetic positional sensor.
 29. The system of claim 21, wherein the machine-readable instructions, when executed by the processor, further cause the control system to issue a feedback cue indicating a user-identified planned deployment location based on a user input is objectionable.
 30. The system of claim 29, wherein the interventional tool comprises a biopsy needle, and wherein the user-identified planned deployment location is determined to be objectionable based on a determination that the biopsy needle cannot reach the target structure from the user-identified planned deployment location.
 31. A method of planning an interventional procedure by a control system, the method comprising: receiving a model of an anatomic structure, the anatomic structure including a plurality of passageways; identifying a target structure in the model; receiving information about a maximum extension length an interventional tool can be extended relative to a distal tip of a catheter; and based upon the received information about the maximum extension length, identifying a planned deployment location for positioning the distal tip of the catheter to perform the interventional procedure on the target structure.
 32. The method of claim 31, further comprising: receiving image data captured by an imaging system; and based upon the information received about the maximum extension length of the interventional tool and the image data, identifying a plurality of optional deployment locations for positioning the distal tip of the catheter to perform the interventional procedure on the target structure.
 33. The method of claim 32, further comprising: displaying the plurality of optional deployment locations in the model on a display system, wherein each of the plurality of optional deployment locations is displayed with an indication of a relative quality of each respective optional deployment location, the relative quality of each of the plurality of optional deployment locations based on the information received about the maximum extension length.
 34. The method of claim 31, wherein the interventional tool comprises an imaging probe.
 35. The method of claim 31, further comprising tracking movement of the interventional tool relative to the catheter using an insertion sensor.
 36. The method of claim 35, wherein the insertion sensor comprises an encoder.
 37. The method of claim 31, further comprising tracking movement of the interventional tool relative to the catheter based on a motor used to control insertion of the interventional tool.
 38. The method of claim 31, further comprising tracking movement of the interventional tool relative to the catheter using an electromagnetic positional sensor.
 39. The method of claim 31, further comprising issuing a feedback cue indicating a user-identified planned deployment location based on a user input is objectionable.
 40. The method of claim 39, wherein the interventional tool comprises a biopsy needle, and wherein the user-identified planned deployment location is determined to be objectionable based on a determination that the biopsy needle cannot reach the target structure from the user-identified planned deployment location. 